NCT04718090

Brief Summary

Early postoperative pain after shoulder surgery is a major concern and distress for patients and orthopedic surgeons. Adequate pain control; It is vital for all aspects of patient recovery, including mental state, nutrition, cost of care period, rehabilitation, patient satisfaction, and overall post-surgery outcomes.Single analgesic regimens are not always effective in controlling moderate to severe postoperative pain.Therefore, multimodal pain management is preferred and is currently recommended for early postoperative pain control.Regional anesthesia is preferred in shoulder surgery as an effective way to provide anesthesia and postoperative analgesia.To ensure adequate postoperative pain control, nerve supply to the synovium, capsule, joint surfaces, ligaments, periosteum and shoulder muscles must be blocked.Interscalene blocks are well studied and established means of providing analgesia following shoulder surgery and are considered the gold standard mode of regional anesthesia.Pericapsular nerve group block is a new block that provides a pericapsular distribution with local anesthetic infiltration around the glenohumeral joint and provides analgesia without motor blockage by reaching the sensory nerve branches of the glenohumeral joint.The aim of this study was to compare the results between interscalene block and pericapsular nerve group block in patients undergoing shoulder surgery.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

January 17, 2021

Last Update Submit

January 20, 2021

Conditions

Visual Analogue Score

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    Visual Analogue Scale

    5 months

Study Arms (2)

interscalene block

ACTIVE COMPARATOR
Procedure: PENG Block

PENG block

ACTIVE COMPARATOR
Procedure: PENG Block

Interventions

PENG BlockPROCEDURE

Pericapsular nerve group block in shoulder surgery.

PENG blockinterscalene block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and over
  • American Society of Anesthesiologists (ASA) 1 and 2
  • shoulder surgery

You may not qualify if:

  • under 18 years old
  • American Society of Anesthesiologists (ASA) 3 and above
  • who are allergic to local anesthetics
  • patients with infection at the injection site
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Patel MS, Abboud JA, Sethi PM. Perioperative pain management for shoulder surgery: evolving techniques. J Shoulder Elbow Surg. 2020 Nov;29(11):e416-e433. doi: 10.1016/j.jse.2020.04.049. Epub 2020 Jun 9.

    PMID: 32844751RESULT

  • Sripada R, Bowens C Jr. Regional anesthesia procedures for shoulder and upper arm surgery upper extremity update--2005 to present. Int Anesthesiol Clin. 2012 Winter;50(1):26-46. doi: 10.1097/AIA.0b013e31821a0284.

    PMID: 22227421RESULT

  • Yamak Altinpulluk E, Teles AS, Galluccio F, Simon DG, Olea MS, Salazar C, Fajardo Perez M. Pericapsular nerve group block for postoperative shoulder pain: A cadaveric radiological evaluation. J Clin Anesth. 2020 Dec;67:110058. doi: 10.1016/j.jclinane.2020.110058. Epub 2020 Sep 26. No abstract available.

    PMID: 32987232RESULT

  • Tran J, Peng PWH, Agur AMR. Anatomical study of the innervation of glenohumeral and acromioclavicular joint capsules: implications for image-guided intervention. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100152. doi: 10.1136/rapm-2018-100152. Online ahead of print.

    PMID: 30635516RESULT

Central Study Contacts

Merve Yazici Kara, M.D.

CONTACT

+90 533 686 0156merreset@hotmail.com

İlke Kupeli, M.D.

CONTACT

+90 555 548 5632ilkeser2004@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 17, 2021

First Posted

January 22, 2021

Study Start

February 1, 2021

Primary Completion

June 30, 2021

Study Completion

July 31, 2021

Last Updated

January 22, 2021

Record last verified: 2021-01